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Rabies Vaccine Supply Situation

Posted: July 15, 2008

Current Situation

Novartis Vaccines now has announced that RabAvert® (Rabies Vaccine for Human Use) is again available, for post-exposure prophylaxis use only.

To obtain RabAvert for post-exposure prophylaxis, medical providers will be required to receive approval through their Rabies State Health Officials. At that time, medical providers will receive a confirmation code from the officials. The code is required to place an order through Novartis Vaccines.

Novartis anticipates additional vaccine supply availability by this fall and will work with the CDC to ensure its availability for both pre- and post-exposure prophylaxis.

Last month, Novartis broke ground on a new rabies production facility in Marburg, Germany. The plant is expected to be operational in 2011.

Vaccine availability for pre-exposure vaccination is quite limited, and will be distributed on approval from state and federal public health authorities for those with a critical need and in consideration of available supplies. These measures will allow responsible management of currently limited supplies of this vaccine for those individuals at highest risk of exposure.

Both Novartis Vaccines and Sanofi Pasteur remain in close contact with public health authorities to ensure that guidelines for appropriate usage of vaccine for PEP is communicated to medical providers.

Discussions among federal, state, and local public health personnel are ongoing to review additional strategies to manage this situation.

Why is there an interruption in supply?

This report provides an update to information posted previously on 6/16/2008.

Starting in June 2007, Sanofi Pasteur began renovating its IMOVAX Rabies vaccine production facility in France to maintain compliance with the most current requirements from FDA and the French regulatory body. Prior to these renovations, Sanofi Pasteur established an inventory based on historical levels of sales and projected market demand. The facility is scheduled to be approved and operational by mid-to-late 2009. Until the facility is operational, Sanofi Pasteur has a finite amount of IMOVAX Rabies vaccine.

After the renovations began, Novartis, the other supplier of rabies vaccine for the United States, was unable to meet projected rabies vaccine supplies.

Since early 2008, Novartis has been supplying its rabies vaccine, RabAvert, for post-exposure use only. Consequently, Sanofi Pasteur has been supplying nearly all of the market for rabies vaccine. The increase in demand for IMOVAX is outpacing the company s historical levels of supply.

How does this affect current rabies vaccination recommendations?

Pre-EP should be delayed until vaccine is available. It is expected that additional vaccine will be available again approximately in July 2008.

Persons at increased risk for rabies exposure should take appropriate precautions to avoid rabies exposure.

Vaccine is available for PEP, and providers should consult with their local or state public health department to ensure appropriate use of PEP.